NICARDIPINE HYDROCHLORIDE | A090534 | AMERICAN REGENT INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps and McNamara, P.C. (on behalf of Exela Ph... FDA-2021-P-0308 · 3 docket documents Exela Pharma Sciences, LLC, through counsel at Hyman, Phelps and McNamara, P.C., filed this citizen petition under Section 505(b) of the FDC Act requesting that FDA assign a Therapeutic Equivalence Evaluation Code to its nicardipine hydrochloride injection NDA 022276, refund PDUFA user fees improper | 505(q) | 2021-03-19 | Open | Exela Pharma Sciences, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.